The US Food and Drug Administration has officially given Medtronic, a global leader in healthcare technology, an approval for the latter’s closed-loop rechargeable spinal cord stimulator (SCS) called Inceptiv. According to certain reports, Inceptiv arrives on the scene as world’s first ever SCS device to offer a closed-loop feature that senses biological signals along the spinal cord, and at the same time, adjusts stimulation in real time so to keep therapy in harmony with the motions of daily life. Before we dig any further into this development, though, we must acknowledge that, while fixed-output SCS devices useconstant, mild electrical impulses to disrupt pain signals before they reach the brain, they make certain movements, such as laughing, bending, or sneezing, uncomfortable over time due to overstimulation. This, like one might guess, makes for a suboptimal therapy experience. Talk about how Medtronic’s newly-approved brainchild will solve the given problem, it will do so by sensing signals and consistently maintaining the physician’s prescribed stimulation. In practice, the whole mechanism involves specialized circuitry and a proprietary algorithm detecting ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. To give you some context, ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord, and therefore, they can be used to inform real-time adjustments for stimulation. Hence, leveraging that setup, Inceptiv senses body’s response to stimulation 50 times per second, while simultaneously boasting the facility to increase or decrease stimulation and maintain prescribed settings as determined by the physician.
“A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront,” said David Carr, vice president and general manager of Pain Interventions within Medtronic’sNeuromodulation business, which is part of thecompany’s Neuroscience Portfolio. “For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS.”
Another detail worth a mention regarding this device would be its ability to offer diagnostic imaging, with 1.5T and 3T full-body MRI access and no power or impedance restrictions. Markedly enough, as of today, Inceptiv is the only FDA-approved closed-loop spinal cord stimulator which offers full-body 3T MRI access. Contextualizing the importance of such a feature is the fact that nearly 84% of SCS-implanted patients are expected to need at least one MRI within five years of implant. Anyway, Inceptiv SCS even allows you the option of multiple waveforms types, including Medtronic’s proprietary DTM™ SCS therapy. This therapy, in case didn’t know has demonstrated an 84% responder rate over 12 months during a large, multicenter randomized controlled trial (RCT). On top of that, we must mention how patients using Inceptiv SCS can also gain access to CareGuidePro™, a mobile application and web portal that serves as a virtual guide throughout their Medtronic spinal cord stimulation therapy journey.
“Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment,” said Dr. Krishnan Chakravarthy, M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation. “Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain.”
